Diagnostic testing for immunologic food sensitivity

ABSTRACT

In various implementations, a noninvasive, food sensitivity test may be utilized to identify one or more food sensitivities. A fecal sample may be obtained. The food sensitivity test may be performed on the obtained fecal sample. One or more food sensitivities may be identified based on the food sensitivity test.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional PatentApplication No. 62/149,136, entitled “DIAGNOSTIC TESTING FOR IMMUNOLOGICFOOD SENSITIVITY,” filed on Apr. 17, 2015, which is hereby incorporatedby reference for all purposes.

TECHNICAL FIELD

The present invention relates to food sensitivity testing in patients.

BACKGROUND

Currently, chronic immunological food sensitivities (e.g., to bedistinguished from acute allergy) and/or intolerance in people may bedifficult and/or expensive to identify. Many food products are processedand/or genetically engineered to include portions of other types foodsthat may not be expected in a product. For example, corn chips mayinclude wheat gluten. Thus identifying food sensitivities from anelimination diet may be difficult. In addition, needless eliminationdiets (e.g., when food sensitivities are not present) may causeunintended calorie restriction and/or nutritional deficiencies. Scratchtests and blood tests may be expensive, cause discomfort, and/or preventsome people from pursuing testing. Furthermore, since children and/orsome adults (e.g., adults with impaired abilities) may not be able toaccurately tell others about their experiences, food sensitivities maygo unnoticed and/or may be difficult to ascertain and continue to causeimmunological reactions. Undiagnosed food sensitivities may causeprolonged immunological reactions, which contribute to the poor healthof an individual, and may cause or complicate management of otherdiseases and/or disorders.

SUMMARY

In various implementations, a noninvasive, food sensitivity test may beutilized to identify one or more food sensitivities and/or facilitateidentification of diseases and/or disorders. The food sensitivitytesting system may include a food sensitivity test, fecal samplecollection set (e.g., tools to transfer feces, specimen container, fecalsample collection device, etc.), and/or other components. A fecal samplefrom a patient may be obtained. The food sensitivity test may beperformed on the obtained fecal sample. One or more food sensitivitiesmay be identified based on the performance of the food sensitivity teston the fecal sample. In some implementations, one or more diseases ordisorders associated with the identified food sensitivity may beidentified.

In various implementations, a diagnostic test kit may identify foodsensitivity in humans. The kit may include a diagnostic test to identifythe presence of a first set of food sensitivities in a human. Thediagnostic test may include a substrate and a test region. The testregion may include antibody binding agent(s) coupled to the substrate.The antibody binding agent(s) may couple with first antibodies,associated with one or more of the foods sensitivities in the first setof food sensitivities, when the first antibodies are present in a fecalsample obtained from the human. The diagnostic test may contact thefecal sample of the human to allow identification of the presence of thefirst set of food sensitivities. The first antibodies, if present in thefecal sample, may be transferred to the test region of the diagnostictest by the contact.

Implementations may include one or more of the following features. Thediagnostic test may be a stick test. The stick test may include a firstend and an opposing second end. The first end of the stick test mayinclude a handle to allow a user to hold the stick test withoutcontacting the fecal sample. The second end of the stick test maycontact the fecal test to allow transfer of one or more of the firstantibodies, if present in the fecal sample, to the test region of thediagnostic test. The diagnostic test may include an absorbent region totransfer a testing portion of a fecal sample from the fecal sample tothe test region of the diagnostic test. The absorbent region may contactthe fecal sample and absorbs fluid from the fecal sample to transfer tothe test region. The fluid from the fecal sample may include at least aportion of the antibodies present in the fecal sample. The diagnostictest may include one or more flags to indicate coupling of one or morefirst antibodies in a fecal sample with one or more of the antibodybinding agents of the diagnostic test. The flag(s) may provide a visualindication that at least one of the first set of food sensitivities ispresent in the human associated with the fecal sample. The diagnostictest may allow fluid from the fecal sample to flow between two or moreregions of the diagnostic test. The antibody binding agent(s) mayinclude an IgA conjugate associated with an IgA antibody associated withone or more food sensitivities in the set of food sensitivities, whereinthe IgA conjugate binds to the IgA antibody when the IgA antibody isproximate the IgA conjugate. The testing region of the diagnostic testincludes flag(s) coupled to one or more of the antibody binding agentssuch that flag(s) are altered when an antibody from a fecal samplecouples with an antibody binding agent. Altering one or more of theflags produces a visually identifiable change. The testing region mayinclude a plurality of different antibody binding agents associated withdifferent food sensitivities. In some implementations, the diagnostictest may be integrated with a specimen container. The specimen containermay allow a testing portion of the fecal sample to be disposed in thespecimen container to allow identification of the first set of foodsensitivities. The diagnostic test may be positioned in the specimencontainer to allow contact with the testing portion of the fecal sample.

In various implementations, a diagnostic test kit may identify foodsensitivity in humans. The kit may include a fecal sample collectiontool and one or more diagnostic tests integrated in the fecal samplecollection tool. The diagnostic tests may identify the presence of afirst set of food sensitivities in a human. The diagnostic test(s) mayinclude a substrate and a test region. The test region may include oneor more antibody binding agents coupled to the substrate. At least oneof the antibody binding agents may couple with one or more firstantibodies associated with the first set of food sensitivities when oneor more of the first antibodies is present in the fecal sample obtainedfrom the human. The fecal sample collection tool may allow one or moreof the diagnostic tests to contact the fecal sample to allowidentification of the presence of the first set of food sensitivities.The first antibodies, if present in the fecal sample, may be transferredto the test region of the diagnostic test by the contact.

Implementations may include one or more of the following features. Oneor more of the food sensitivity tests may be positioned in the fecalsample collection tool such that the food sensitivity test(s) contactsthe fecal sample. One or more of the food sensitivity tests may bepositioned on the fecal sample collection tool such that a testingportion of the fecal sample is moved to contact the food sensitivitytest(s) and allow identification of the first set of food sensitivities.The fecal sample collection tool may include opening(s) to allow atleast a portion of fluid from a fecal sample to drain from the fecalsample collection tool. The fecal sample collection tool may allow ahydrating agent and/or a solution including flags to be applied to thefecal sample in the fecal sample collection tool. The diagnostic test(s)may include flag(s) to indicate coupling of one or more first antibodiesin the fecal sample with one or more of the antibody binding agents inthe diagnostic test(s). The flag(s) may provide a visual indication thatat least one of the first set of food sensitivities is present in thehuman associated with the fecal sample. The fecal sample collection toolmay include a removable stop. The stop may close an opening in the fecalsample collection tool, and when the stop is removed at least one offluid and/or the fecal sample may be drained from the fecal samplecollection tool via the opening. The diagnostic test may include aplurality of antibody binding agents associated with a set of foods. Atleast one of the antibody binding agents may include an IgA conjugateassociated with an IgA antibody associated with one or more foodsensitivities in the set of food sensitivities. The IgA conjugate maybind to the IgA antibody when the IgA antibody is proximate the IgAconjugate. The testing region may include one or more flags coupled toone or more of the antibody binding agents such that when an antibodycouples with an antibody binding agent the flag is altered. Thediagnostic test(s) may provide a visually identifiable change toidentify the presence of the first set of food sensitivities in thefecal sample.

The details of one or more implementations are set forth in theaccompanying drawings and the description below. Other features,objects, and advantages of the implementations will be apparent from thedescription and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of this disclosure and its features,reference is now made to the following description, taken in conjunctionwith the accompanying drawings, in which:

FIG. 1A illustrates an implementation of an example food sensitivitytest.

FIG. 1B illustrates an implementation of the example food sensitivitytest illustrated in FIG. 1A, during use.

FIG. 2 illustrates an implementation of an example process for testingfor food sensitivities.

FIG. 3 illustrates an implementation of an example integrated fecalcollection tool.

FIG. 4A illustrates an implementation of an example integrated fecalcollection tool.

FIG. 4B illustrates an implementation of the example integrated fecalcollection tool illustrated in FIG. 4A in which the collar has beenremoved.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION

In various implementations, a food sensitivity testing system may beprovided. Food sensitivities may include immunological reactions in aperson in response to ingesting, consuming, injecting, and/or contactingfoods or portions thereof. For example, when a person experiencessensitivity to an immunogenic food, the food may act as an antigen andthe person's body may produce antibodies specific to the antigen (e.g.,the food). The produced antibodies may include Immunoglobulin A (IgA).When a person consumes a food that acts as an antigen in the body, thefood specific IgA in the body may bind to the antigen (e.g., the food)and cause an immunological reaction and/or symptom (e.g., inflammation,diarrhea, nausea, etc.). Since IgA is produced in mucosal linings andpresent in the gastrointestinal tract, feces from the person may includeIgA.

In various implementations, the food sensitivity test may be noninvasivesince the food sensitivity test is performed on a fecal sample. Inpatients, such as children and impaired adults (e.g., intellectualdisabilities, dementia, Alzheimer's, etc.), invasive tests, such asblood tests and skin tests may cause patient fear and/or discomfort. Inaddition, blood collection from children is difficult due to patientfear and small blood vessel sizes. Thus, patient fear and/or discomfortmay be reduced (e.g., when compared with invasive testing) using thefood sensitivity test. In some patients, blood collection is impracticaldue to underlying health issues (e.g., poor clotting due to healthand/or medications).

When food sensitivities are determined based on fecal samples, thelevels of Immunoglobin A (IgA) present in the fecal sample are utilizedto identify food sensitivities. In some implementations, measurement ofIgA may provide a more accurate reflection of food sensitivities relatedto the mucus secretions and/or gastrointestinal system (e.g., than IgE)since IgA is produced in mucosal linings and is present in thegastrointestinal tract. In some implementations, sampling blood for IgA,IgG, or IgE antibodies may accompany and/or complement the fecal IgAtesting.

The identification of food sensitivities may be utilized to diagnosesymptoms, such as chronic gastrointestinal symptomatology (including butnot limited to vomiting, diarrhea, constipation, foul/malodorousflatulence and/or stools, and abdominal bloating), behavioral problems,or chronic immune/auto-immune sequelae; and/or specific disorders anddiseases, including gluten-sensitive enteropathy, Crohn's Disease,and/or irritable bowel syndrome; reduce immunological sensitivities(e.g., by eliminating the identified food); and/or other appropriatepurposes. In some implementations, the food sensitivities identified bytesting fecal samples and/or diagnoses of patients may be further testedusing conventional methods, such as ELISA blood serum testing, skinprick testing, and/or endoscopy.

In various implementations, the food sensitivity test may include atesting region on a substrate. The substrate may include a plate (e.g.,nanoparticle plate, microfluidic array, sensor on chip, etc.), a teststrip, a stick such as the food sensitivity test stick described in FIG.1, a container (e.g., a cup and/or bowl), and/or other appropriatetesting substrate. In some implementations, the fecal sample may becollected directly in and/or on the substrate. The fecal sample may becollected and transferred to the substrate of a food sensitivity test,in some implementations.

The testing region may include antibody binding agent. The antibodybinding agent may include a compound with a receptor capable ofselectively binding (e.g., the antibody binding agent may not bind withone or more other antibodies) with a predetermined antibody. Forexample, the antibody binding agent may include an antibody conjugate,such as an IgA conjugate (e.g., corn IgA conjugate, wheat IgA conjugate,etc). The antibody binding agent may be disposed on a substrate of thefood sensitivity test. The antibody binding agent may be applied to thetesting region prior to and/or before the fecal sample or portionsthereof are disposed on the testing region. The antibody binding agentsmay be bound (e.g., immobilized and/or coupled via methods similar toELISA) on the testing region, in some implementations. For example,antibody binding agents, such as antigens, may be bound on a substrateof the testing region. For example, when a food sensitivity test isadapted to identify corn sensitivities, the antibody binding agent maybe adapted to selectively bind with corn IgA (e.g., IgA produced inresponse to an immunological food sensitivity reaction to corn) whilebeing inhibited from coupling with other types of IgA, such as wheatIgA, egg IgA, corn IgE, etc. By utilizing antibody binding agents thatselectively couple with predetermined antibodies (e.g., rather thancoupling with predetermined antibodies and other antibodies), falseindications of food sensitivities may be reduced (e.g., when compared atest that utilizes nonselectively coupling antibody binding agents). Insome implementations, the antibody binding agent may be coupled bypassive adsorption to a test region of the substrate. For example, asolution of the antibody binding agent (e.g., in an alkaline buffersolution) may be contacted with substrate(s) and allowed to incubate.Then the solution may be removed or washed off such that antibodybinding agents remain coupled to portion(s) of the substrate.

The coupling between the antibody binding agent and the predeterminedantibody may be chemical coupling and/or affinities between regions ofthe antibody binding agent and the predetermined antibody. For example,an antibody binding agent may include an antigen for a predeterminedantibody. When the antibody is in the presence of the antibody bindingagent (e.g., antigen), the antibody and the antibody binding agent(e.g., antigen) may couple. The antibody binding agent (e.g., IgAconjugate) may include a receptor capable of coupling with apredetermined portion of a predetermined antibody. . For example, anantibody binding agent may include an antigen (e.g., corn IgA conjugateand/or other appropriate antigens) for a predetermined antibody (e.g.,corn IgA, antigliadin IgA, antitissue transglutaminase IgA antibody;and/or other appropriate antibodies). The predetermined portion of theantibody may not be present on one or more other antibodies, and thusbinding of the antibody binding agents with one or more other antibodiesmay be inhibited.

During use, the fecal sample or portions (e.g., testing portion) thereof may be provided to (e.g., contacted with, pass over, etc.) thetesting region of the food sensitivity test. The predeterminedantibodies (e.g., that the test is seeking to identify), if present inthe fecal sample, may bind with the antibody binding agents in thetesting region. The use of flags with the food sensitivity test mayfacilitate identification of the antibody-antibody binding agentcoupling.

The food sensitivity test may include a flag to provide notifications toa user. For example, the food sensitivity test may include a flag thatidentifies predetermined couplings (e.g., between the antibody bindingagent and the antibody, between a flag binding agent and the flag,etc.). The flags may be disposed in a flag region of the foodsensitivity test, coupled to antibody binding agents, and/or otherwiseprovided with the food sensitivity test.

The flag may include, for example, color markers, radioopaque markers,magnetic markers, fluorescent label (e.g., via a fluorophore), and/orany other appropriate flag (e.g., flags that provide audio, visual,and/or tactile indications). Utilizing flags may facilitateidentification of predetermined couplings, such as between antibodybinding agents and predetermined antibodies, and thus facilitateidentification of food sensitivities. Utilizing flags may ease use byusers, in some implementations. For example, a user may be able to viewthe food sensitivity test and determine the results based onvisualization of the flags or lack of flags. In some implementations,when the antibody binding agent and antibody bind, the flag may changecolors (e.g., not visible to visible; white to red; red to blue;fluoresce; and/or combinations thereof). The user may then compare thechanged color to an instruction set to determine if a food sensitivityexists based on the results (e.g., instruction set may include a colorchart, color intensity chart, etc. that associates visual cues withresults such as a specific set of food sensitivities).

In some implementations, the fecal sample may be processed prior tocontacting the testing region. In some implementations, processing thefecal sample may include coupling a flag to predetermined antibodies, ifpresent, in the fecal sample. For example, a solution comprising theflags may be allowed to wash over at least a portion of the fecalsample. In some implementations, at least a portion of the fecal samplemay be allowed to flow through a region of the food sensitivity testthat includes flags. If predetermined antibodies are present in thefecal sample, one or more of the flags may be coupled to thepredetermined antibodies. In some implementations, a hydrating solution(e.g., water, saline, and/or other appropriate solutions) may be addedto the fecal sample to allow testing. For example, if a fecal sample isdry, water may be added to the fecal sample. In some implementations,the fecal sample may be mixed or otherwise agitated (e.g., to produce anapproximately homogenous fecal sample). In some implementations, anundiluted fecal sample may be provided to the testing region of the foodsensitivity test.

In some implementations, the test region of the food sensitivity testmay include a control. The control may provide an indication that thefood sensitivity test is capable of identifying predeterminedantibodies. For example, the control may include flag binding agents.The flag binding agents may be capable of selectively coupling with theflag present in the food sensitivity test and may not be capable ofbinding with other flags. When a flag contacts the control of the testregion, the flag may bind with the flag binding agent and provide anindication, such as a color change.

The user may utilize the results of the food sensitivity test to providean initial and/or dispositive indication of a food sensitivityassociated with the set of antibodies for which the test was selected.In some implementations, the user may follow up the results withadditional home testing, clinical testing, and/or laboratory testing offecal samples, blood samples, and/or other testing (e.g., examination ofintestines). After food sensitivity is identified using the foodsensitivity test, disorders and/or diseases associated with the foodsensitivity may be identified based at least partially on the one ormore food sensitivities identified using the food sensitivity test. Forexample, if gluten sensitivity is identified by the food sensitivitytest, Crohn's disease may be identified in the person based on theresults of the food sensitivity test and/or other medical informationabout the person (e.g., weight loss, no cancer detected).

In some implementations, a first food sensitivity test may be utilizedwith a fecal sample or portion thereof (e.g., testing portion) from anindividual to determine whether a set of food sensitivities is present.One or more subsequent food sensitivity tests may be performed based onthe results of the first food sensitivity test. For example, if theresults of the first food sensitivity test indicate (e.g., via coloralteration) a food sensitivity but not which food sensitivity in the setof food sensitivities, then one or more second food sensitivity testsmay be performed to determined which of the food sensitivities in theset is present in the individual being tested (e.g., if a set for thefirst test includes corn, wheat and dairy, the second test may test forcorn and wheat and a third test may test for dairy; if a set for a firstset includes wheat, dairy and eggs, the subsequent tests may test foreach item individually). In some implementations, if the results of thefirst food sensitivity test does not indicate (e.g., no color change)that any of the food sensitivities in the set of food sensitivities arepresent in the individual, further testing may not be performed and/orsubsequent testing on different sets of food sensitivities may beperformed.

In some implementations, the food sensitivity testing system may includea home kit. The home kit may include a fecal sample container, foodsensitivity test, and/or instructions.

In various implementations, the food sensitivity testing system mayinclude a food sensitivity test, fecal sample kit, and/or othercomponents. The food sensitivity test may be selected to facilitate usein a home setting. For example, the food sensitivity test may be singleuse, self-contained (e.g., washing with specialty reagents may not beperformed), easy to use, and/or cost-effective. The food sensitivitytest may allow fecal sample testing without processing and/or withminimal processing (e.g., stirring and/or diluting). The foodsensitivity test may allow testing of undiluted fecal samples, in someimplementations.

FIG. 1A illustrates an implementation of an example of a foodsensitivity test 100. FIG. 1B illustrates the food sensitivity test 100during use. The food sensitivity test 100 may allow rapid, easy to readresults. Using the food sensitivity test may be easier for users, sincethe stick may not include steps such as washing plates with specializedreagents, complex ordering of steps, applying flags, and/or specializedvisualization of flags (e.g., via microscope, via radioimaging, and/orvia other visualization methods). In addition, fecal sample testing maybe performed without additional processing and/or lengthy additionalprocessing steps, in some implementations.

The food sensitivity test may include a first end and a second opposingend. At least a portion of the food sensitivity test 100 (e.g.,proximate the first end) may be disposed in a housing 110. The housing110 may allow a user to hold the food sensitivity test 100 withouttouching one or more regions of the food sensitivity test stick (e.g.,the absorbent region 120) and/or the fecal sample. The second end of thefood sensitivity test may be contact a fecal sample to allow testing ofthe fecal sample. For example, the second end may be positioned in(e.g., stuck in, pushed in, etc.) the fecal sample to allow testing. Insome implementations, the second end of the food sensitivity test may bepositioned in a wet portion of the fecal sample to encourage fluid(e.g., containing IgA from the fecal sample) flow from the fecal sampleinto the food sensitivity test.

The food sensitivity test 100 may include an absorbent region 120, aflag region 130, and a test region 140. The regions of the foodsensitivity test 100 may be on a substrate, such as a continuoussubstrate. In some implementations, the regions may not be on acontinuous substrate and the food sensitivity test may allow fluid flowbetween one or more regions. The substrate may include absorbent pad(s),woven fiber(s) (e.g., synthetic and/or natural fibers), microfluidicchannel(s) and/or paper(s), in some implementations.

The absorbent region may draw fluid into the food sensitivity test fromthe fecal sample. For example, the absorbent region may draw fluid froma fecal sample at least partially into one or more other regions of thefood sensitivity test stick. The absorbent region may draw at least aportion of the fluid by absorption, capillary action, pressuredifferentials, pumping (e.g., pipette and bulb), and/or any otherappropriate fluid transport mechanism. In some implementations, watermay be added to the fecal sample to facilitate drawing at least aportion of the fecal sample into the food sensitivity test stick. Insome implementations, the fecal sample may include enough water to allowat least a portion of the fecal sample (e.g., water and/or antibodies inthe fecal sample) to be drawn into the food sensitivity test stick.

The absorbent region of the food sensitivity test stick may be placed incontact with the fecal sample (e.g., by pushing the absorbent pad intothe fecal sample, by placing the absorbent pad in the supernatant watercollected from a centrifuged fecal sample, etc.). As illustrated in FIG.1B, the absorbent region 120 may transport at least a portion of one ormore fluids 250 from the fecal sample through the absorbent region andto another region, such as the flag region 130, of the food sensitivitytest 100.

In the flag region, the testing portion of the fecal sample (e.g., aportion of the fecal sample) may flow at least partially through theflag region. In the flag region, flag may selectively bind topredetermined antibodies, if these predetermined antibodies are presentin the testing portion of the fecal sample. In some implementations,flags in the flag region of the food sensitivity test may be releasedinto the testing portion of the fecal sample as it passes through theflag region and to the test region. The flags may bind to the antibodybinding agents and/or antibodies.

In some implementations, the food sensitivity test stick may not includea flag region. For example, the fecal sample may be contacted with flags(e.g., wash or otherwise apply a solution including flags onto the fecalsample) prior to placing the food sensitivity test stick in contact withthe fecal sample.

The food sensitivity test stick may include a test region. The testregion may include antibody binding agents. The antibody binding agentsmay include any appropriate compound (e.g., enzyme, reagent, antigen)that is capable of selectively binding with a predetermined antibody. Insome implementations, the antibody binding agent for an IgA antibody mayinclude the associated antigen. For example, the antibody binding agentfor the IgA antibody associated with corn sensitivity may include cornantigen (e.g., corn or portions thereof, such as proteins of the corn,as the antigen). If IgA antibody associated with corn is present in afecal sample, it will bind with corn antigen. The corn antigen may notbind with other IgA present in the fecal sample, such as IgA associatedwith dairy. Thus, a sensitivity to corn may be identified through theselective coupling of the antibody with an antibody binding agent. Byutilizing antibody binding agents that selectively couple withpredetermined antibodies (e.g., rather than coupling with predeterminedantibodies and other antibodies), false indications of foodsensitivities may be reduced (e.g., when compared a test that utilizesnonselectively coupling antibody binding agents).

In the testing region, the flag may be visible or otherwise apparent(e.g., tactile signal) when the antibody, the antibody binding agent andthe flag are coupled. Thus, the presence of a predetermined antibody maybe identified based on the visualization or other identification of theflag. As illustrated in FIG. 1B, when the flag is coupled to the control(e.g., including flag binding agents), a visible signal 260 may beproduced in the test region 140. When the antibody is coupled to theantibody binding agent, the flag may produce, for example, a visiblesignal 270 in the test region 140. In some implementations, the testingregion may include an immunoassay strip.

In some implementations, the flag region and the test region of the foodsensitivity test stick may be combined. In some implementations, theflags may be coupled to the control and/or antibody binding agents. Forexample, flags may be coupled to the antibody binding agents and/or withthe control region of the food sensitivity test stick. In someimplementations, the flags may be disposed in the testing region and asfluid (e.g., from the fecal sample) travels at least partially throughthe testing region, the fluid may contact flag(s) and/or antibodybinding agents. In some implementations, the flags may be coupled to theantibody binding agent and the flags may provide an indication when theantibody binding agent is coupled to a predetermined antibody. In someimplementations, the control may provide an indication that the foodsensitivity test is capable of identifying food sensitivities byproviding an indication that fluid is present in the testing region(e.g., rather than identifying the presence of flags).

The food sensitivity test allows food sensitivities to be identifiedbased on signals provided by the food sensitivity test. For example, auser may select a set of food sensitivities for which to test. Since theantibodies for different foods may be different, a test is associatedwith a set of food sensitivities based on which antibody binding agentsare present in the testing region. The user may then select theappropriate food sensitivity test based on the type(s) of food to betested. For example, since the antibodies associated with wheatsensitivity may be different to the antibodies associated with eggsensitivity, the antibody binding agents on the food sensitivity testfor each a set of foods may be different to allow the selective couplingbetween the predetermined antibody and antibody binding agent. The user(e.g., while holding the housing of the food sensitivity test) may allowthe absorbing region of the food sensitivity test to contact a fecalsample (e.g., feces or portions thereof) from a user. The fecal samplemay include fluids (e.g., water, urea, and/or mucus) and the fluids mayinclude antibodies, if present in the fecal sample. At least a portionof the fluid from the fecal sample may be drawn into the absorbentregion of the food sensitivity test (e.g., via capillary action,absorption, drawn to materials in the absorbent region). At least aportion of the fluid in the absorbent region may be drawn (e.g., viacapillary action, absorption, pressure differential, and/or or otherwisedrawn) between the various regions of the food sensitivity test.

At least a portion of the fluid in the absorbent region may be allowedto flow from the absorbent region to the flag region. In the flagregion, if antibodies, associated with the food sensitivities for whichthe test is selected, are present in the fluid from the fecal sample,the antibodies may couple with flag(s). For example, the flag(s) may beembedded in the material of the flag region and as the fluid from thefecal sample passes through the flag region, the flags may be releasedand selectively bind with one or more specific antibodies, if present.The specific antibodies may be the antibodies associated with the foodsensitivities for which the food sensitivity test is selected. Thefluid, possibly including the specific antibodies bound to flags, maythen pass to the testing region. In the testing region, antibody bindingagents may be present (e.g., coupled to the testing region, washed overthe testing region). The fluid may pass proximate the antibody bindingagents. If specific antibodies are present in the fluid, the antibodybinding agents and the specific antibodies may couple. When the antibodybinding agent and the specific antibody couple, the flag may provide anindication (e.g., visible color) of the presence of the coupledantibody. In some implementations, the food sensitivity test may includea control. The control may, for example, include flag binding agents. Asthe fluid from the fecal sample passes through the testing region, thefluid may pass proximate the control. The flag binding agents may couplewith flags (e.g., coupled flags and/or uncoupled flags) in the fluid. Insome implementations, the antibody binding agents and/or the control maybe coupled to the testing region in a specific pattern to facilitateidentification (e.g., lines, circles, etc.). In some implementations, anintensity of the indication provided by the flags (e.g., intensity ofcolor) may indicate a level (e.g., an approximate relative amount, suchas a ratio, and/or an approximate absolute amount) of antibodies presentin the fecal sample. Thus, based on the indication provided by the flagsin the testing region, a user may be able to identify if the test wasexecuted appropriately (e.g., when the control provides an indication),whether specific antibodies are present, and/or a level of antibodies.

In some implementations, the food sensitivity test may be used todetermine whether a person has a set of food sensitivities. A set offood sensitivities may include one or more food sensitivities. Forexample, a test may be utilized to determine if a person has foodsensitivities to a set of grains. A test may be utilized to determine ifa person has food sensitivities to one or more food substances (e.g.,grain, dairy, and/or eggs, common allergens), in some implementations.Additional testing (e.g., additional food sensitivity tests and/or othertests) may be performed if the food sensitivity test indicatessensitivity to one or more of the food sensitivities associated with thefood sensitivity test.

In some implementations, a food sensitivity test that is associated witha plurality of food sensitivities may or may not distinguish between theindications provided for each of the food sensitivities. For example, afood sensitivity test may be associated with corn sensitivity, wheatsensitivity, and supplement sensitivity. The flag region may include oneor more flags that selectively bind with one or more of the antibodiesassociated with each of these sensitivities. The flag coupled to a firstantibody, such as corn antibody (e.g., the antibody associated with acorn sensitivity), may provide the same indication (e.g., blue and/orfluoresce) as the flag or a different flag in the flag region coupledwith one or more of the other antibodies associated with the test (e.g.,wheat antibody and/or supplement A antibody). Thus, the indicationprovided by the flag in the testing region may identify one or more foodsensitivity (e.g., by the indication provided by the flags coupling withantibodies and antibody binding agents) and may not distinguish betweenthe different food sensitivities.

In some implementations, when a food sensitivity test is associated withtesting a plurality of food sensitivities, the food sensitivity test mayallow distinguishing between the food sensitivities identified. Forexample, each food sensitivity may be associated with a flag thatprovides a specific indication (e.g., a specific color). In someimplementations, the food sensitivity may be associated with aparticular part of the testing region. For example, the antibody bindingagents may be coupled to the testing region in lines, and so when anindication is provided along a line of the testing region, the foodsensitivity type may be determined based on the location of the line.

In some implementations, a food sensitivity tests may be performed as aroutine diagnostic test. Since undiagnosed food sensitivities can harm auser, and since a noninvasive test may be performed, the use of the foodsensitivity test may be performed without waiting for symptoms topresent in a patient. For example, newborns may be screened for lactoseand/or soy intolerance. Elderly residents at hospices may be screenedfor food intolerance to common food preparations and/or food supplements(e.g., dietary supplements such as nutritional shakes).

In some implementations, a user who suspects food sensitivities canutilize home food sensitivity tests to diagnose and/or preliminarilyidentify food sensitivities. For example, food sensitivity testing suchas blood tests and/or skin prick tests can be expensive when performedin a clinical setting. The food sensitivity test may allow food testingto be performed cost-effectively, easily (e.g., since fecal samples maynot need to be transported to a laboratory or clinic), and/or whilemaintaining privacy (e.g., since a test can be self-administered).

A user may select a food sensitivity test based on the set of foods tobe tested. A food sensitivity test may allow testing of a set (e.g., oneor more) of predetermined group of foods (e.g., same types of foods,such as grains; set of common allergens, such as dairy, eggs, and wheat;etc.). The food sensitivity test may include antigen binding agents andflags that are capable of coupling with the antibodies produced by theset of foods associated with the food sensitivity test. For example, auser may select a first food sensitivity test for a first set of foodsand a second food sensitivity test for a second set of foods. Thus, auser may select which sets of food sensitivities to test for and whichsets of food sensitivities to skip. In addition, the user may performadditional testing based on the results of a first set of foodsensitivity tests. For example, if a food sensitivity is identified witha first food sensitivity test, then additional testing (e.g., viaadditional food sensitivity tests) may be performed to further identifywhich specific foods or portions thereof (e.g., proteins) cause the foodsensitivity. In some implementations, when a first food sensitivity testdoes not identify food sensitivity to the set of foods associated withthe first food sensitivity test, the user may perform one or moreadditional food sensitivity tests associated with one or more differentsets of foods.

In some implementations, the food sensitivity test may be utilized todetermine efficacy of diet changes. For example, a set of foodsensitivities for an individual may be identified (e.g., based on thefood sensitivity test result) and the individual's diet may be alteredto reduce and/or eliminate one or more of the foods identified.Subsequent food sensitivity test(s) may be performed to determinewhether overall sensitivity has been reduced. In some implementations,one or more foods may be added back into the diet based on thesubsequent testing. For example, if an individual has a “leaky gut”based on inflammation, the individual may have increased overallsensitivity and an initial test may show positive reactivity (e.g.,positive for food sensitivity) for multiple foods. After elimination ofone or more of these foods (e.g., in the set associated with positivefood sensitivity), the individual's overall inflammation and/or overallsensitivity may be decreased. The decrease in inflammation and/orsensitivity (e.g., when compared with the initial test), may identifythe foods for which the individual has food sensitivity and which foodsthat were previously indentified as in the set of foods to which theindividual is sensitive were misidentified based on the overallinflammation. For example, an initial test may identify that anindividual, who has a “leaky gut,” has food sensitivity to wheat, cow'smilk, and soy. After elimination of wheat, cow's milk, and soy from thediet of individual for a first predetermined period, subsequent foodsensitivity test(s) may be performed on fecal samples from theindividual. The subsequent test results may indicate that wheatsensitivity is present but sensitivity to cow's milk and soy is notpresent. The reduction in the sensitivity to cow's milk and soy may bebased on a reduction in overall inflammation and/or sensitivity, and thediet of individual may be adjusted to all reintroduction of one or moreof these items. By allowing subsequent testing, the individual's qualityof life may be improved (e.g., since inflammation may be decreasedand/or symptoms of food sensitivities may be decreased) and/orunnecessary diet and/or calorie restriction may be inhibited.

In some implementations, a fecal sample may be obtained from a user viaa provided specimen container. In some implementations, a user maycollect a fecal sample. For example, the food sensitivity test and/orkit may include a specimen container (e.g., jar, tray). The user may usea collection tool, such as a tongue blade, to transfer a portion offeces collected from a person to the specimen container.

In some implementations, the fecal sample may be further processed priorto testing the fecal sample. The fecal sample may be concentrated. Forexample, the fecal sample may be placed in a centrifuge (e.g., to berotated at speeds of approximately 13,500 rpm to approximately 20,000rpm) and the supernatant fluid may be tested. In some implementations,the fecal sample may be freeze dried (e.g., lyophilized). Water may beadded to the freeze dried fecal sample prior to testing the fecalsample. In some implementations, freeze drying the fecal sample mayfacilitate testing of different types of fecal matter (e.g., wateryfecal matter).

In some implementations, the fecal sample may not be placed into aspecimen container prior to testing the fecal sample with the foodsensitivity test. For example, a user may insert a stick based foodsensitivity test directly into feces from a user. In someimplementations, water may be added to the feces and/or the feces may bemixed with water (e.g., with the collection tool and/or with the foodsensitivity test, such as mixing with the absorbent end of the foodsensitivity test) prior to inserting the food sensitivity test into thefeces.

In some implementations, the fecal collection tool may include anintegrated food sensitivity test. For example, the fecal collection toolmay include a hat like shape or other appropriate shape. FIG. 3illustrates an implementation of an example fecal collection tool 300with an integrated food sensitivity test. The fecal collection tool mayinclude an inner surface and an outer surface. As illustrated, the fecalcollection tool 300 includes a collection portion 310 and a rim 320. Thecollection portion 310 may be shaped and sized to hold a fecal sample.The rim 320 may facilitate fecal collection. As illustrated, the rim 320may extend (e.g., radially) from the collection portion 310; and duringuse, one or more portions of the rim 320 may contact a toilet (e.g.,toilet rim and/or seat). In some implementations, the rim may becollapsible (e.g., the rim may include radial flanges that can becollapsed, the rim may include flanges that collapse in, the rim mayinclude flanges that fold inwards to form a cover, etc.). As illustratedthe fecal collection portion 310 may have walls and a bottom surface.The collection portion 310 may include measuring tools 330, such asmarkings to indicate volume or any other appropriate measuring tool. Themeasuring tools may be disposed on an inner surface of the fecalcollection tool 300. The food sensitivity test 340 may be integratedwith the collection portion 310. As illustrated, the food sensitivitytest 340 may be positioned on a wall of the collection portion and/or ona bottom of a collection portion. In some implementations, multiple foodsensitivity tests may be provided on a fecal collection tool. The foodsensitivity test(s) 340 may be positioned on an inner surface 305 of thefecal collection tool, as illustrated. As illustrated, the opening 350may be disposed proximate a bottom of the fecal collection tool. In someimplementations, a removable stop (e.g., a stop that can be removedand/or reinserted) (not shown) may be disposed in the opening 350 toinhibit fluids and/or solids from flowing through the fecal collectiontool.

In some implementations, the fecal collection tool may have a shape thatallows at least a portion of the container to contact the edges of atoilet, rest in place under the toilet seat, and/or at least partiallybe secured by toilet such that during use, the fecal collection tool mayremain positioned (e.g., not fall completely into toilet bowl to makeremoval of the fecal collection tool more difficult). FIG. 4Aillustrates an implementation of an example fecal collection tool 400and FIG. 4B illustrates the fecal collection tool 400 in which thecollar has been removed. As illustrated, fecal collection tool 400includes a collection portion 410, cover 420, and a collar 430. Thecover 420 may allow the collection portion to be closed (e.g., fortransport, for disposal, etc.). The collar 430 may be removable. Asillustrated, the collar may include an opening in which the collectionportion 410 can be disposed (e.g., without falling through the opening).The collar 430 may include a rim, and the rim or portions thereof maycontact on a portion of a toilet (e.g., rest on or between toilet rimand/or seat) during use. By utilizing a removable rim, the fecalcollection tool 400 may facilitate use. For example, the collar may beattached during fecal sample collection and removed to view testresults, send the fecal sample to a laboratory for further testing, etc.The fecal collection tool may include a food sensitivity test (notshown) on an inner surface of the collection portion. During use, atleast a portion of the fecal sample may contact or be allowed to contact(e.g., a user may move a portion of the fecal sample to contact) thefood sensitivity test. As illustrated, the testing portion 440 and/orresults (not shown) of the food sensitivity test may be visible from anouter surface of the fecal collection tool. For example, the collectionportion may be formed of a transparent and/or translucent material thatallows viewing of the food sensitivity test from an outer surface. Insome implementations, the food sensitivity test may be disposed in anopening of the fecal collection tool and the food sensitivity test maybe viewable from the outer surface. In some implementations, theabsorbent region of the food sensitivity test may be disposed on aninner surface of the fecal collection tool, to allow contact between theabsorbent region and the fecal sample or portions thereof. The testingportion or portions thereof may be disposed on an outer surface of thefecal collection tool to allow viewing of the testing portion and/orresults.

The fecal collection tool may include pan with an opening to allowliquids (e.g., urine) to drain from the pan, while the pan is capable ofholding thicker or solid fecal samples. The opening may allow the fecalsample to be drained from the fecal collection tool after testing (e.g.,for disposal and/or into another container for storage and/or furthertesting). The opening may be disposed in a bottom potion and/or sideportion(s) of the fecal collection tool. The fecal collection tool mayinclude one or more opening(s) that may have any appropriate position,size (e.g., large enough to allow a fluid to drain and/or not largeenough to allow the fecal sample to fall through the opening if a stopis not utilized) and/or shape (e.g., circular, rectangular, etc.). Forexample, the fecal collection tool may include a plurality of slits thatact as openings to allow at least a portion of the fluid to drain fromthe fecal collection tool. In some implementations, the openings mayinclude an opening with a removable stop.

In some implementations, the fecal collection tool may have opening anda stop. For example, the stop may not block the opening during samplecollection (e.g., such that urine may pass); the stop may then beallowed to block the opening to allow testing and/or fecal sampleprocessing. In some implementations, the stop may be allowed to blockthe opening during fecal sample collection and the stop may be removedat a later point (e.g., to drain at least a portion of urine in thefecal collection tool, to drain at least a portion of a flag solutionapplied to the fecal sample in the fecal collection tool, to drain atleast a portion of hydrating solution applied to the fecal sample,and/or to remove the fecal sample from the fecal collection tool). Thefecal collection tool may be capable of coupling or otherwise beingdisposed in a toilet for ease of use. The fecal collection tool mayinclude a testing region disposed in an area of the pan in which fecalsamples may be collected. For example, one or more walls of the pan of afecal collection tool may be slanted to promote contact of the fecalsample with the testing region of the food sensitivity test. The fecalsample may be allowed to remain in contact with a fecal sample collectedin the fecal collection tool for a first period of time. As the fecalsample is in contact with the testing region, antibodies, if present inthe fecal sample, may contact with flags and/or antibody testingregions. In some implementations, water or another hydrating agent maybe provided in the pan to at least partially hydrate the fecal sampleand/or facilitate fluids from the fecal sample flowing proximate and/orin the testing region. After the first period of time the fecal samplemay be moved from the area proximate the testing region, removed fromthe pan and/or the pan may be rinsed (e.g., with water). The user maythen be able to view the testing region and/or indications provided byflags. Food sensitivities may be identified from the indications, aspreviously described. The fecal collection tool may include a handle toallow a user to hold the fecal collection tool in place while notcontacting feces.

In some implementations, the specimen container and the food sensitivitytest may be integrated. For example, a specimen container may include atesting region. For example, the testing region may be disposed on awall or bottom of the container. A portion of a fecal sample may betransferred (e.g., from a diaper) to the specimen container. The fecalsample may contact the testing region and/or water may be added to allowthe fecal sample to hydrate and/or contact the testing region. As thefecal sample is in contact with the testing region, antibodies, ifpresent in the fecal sample, may contact with flags and/or antibodytesting regions to provide indications. The indications may indicate thepresence or absence of food sensitivities. In some implementations,after the first period of time the fecal sample may be moved from thearea proximate the testing region, removed from the pan and/or the panmay be rinsed (e.g., with water). The user may then be able to view thetesting region and/or indications provided by flags. Food sensitivitiesmay be identified from the indications, as previously described.

In some implementations, the food sensitivity test may allow testing ofa plurality of antibodies associated with a single food (e.g., corn,dairy, eggs, a specific supplement). Since a food, food A, may includemore than part that may trigger immunological reactions, an person mayproduce more than one type of antibody in response to contact (e.g.,touching, consuming, etc.) with food A. For example, a species of fishmay have several different types of proteins within the fish. A personthat contacts the fish, by for example eating the fish, may produce morethan one type of antibody in response, if the person has animmunological reaction to the fish. In some people, a person may have areaction to a first protein in the fish but not have a reaction to asecond protein in the fish. An immunological reaction to each of theseproteins may produce different antibodies. Thus, if an immunologicaltest includes an antibody binding agent that selectively couples to theantibody produced in response to the first protein and not the antibodyproduced in response to the second protein, the immunological test mayproduce a false negative (e.g., the person has a food sensitivity but itis not identified by the test). Thus, a food sensitivity test includesantibody binding agents for more than one protein associated with a foodto decrease the rate of false negatives (e.g., when compared with a testthat only includes a single type of antibody binding agent). The flagsmay produce indications for each of the antibody—antibody binding agentbindings that are similar or different based on the type of proteinassociated with the antibody. For example, a home kit may includeseveral types of proteins but not distinguish between sensitivities tothe several proteins (e.g., since a user may not care which protein theperson has a sensitivity but has concerns about a particular food). Insome implementations, a testing kit (e.g., a laboratory kit) may includea food sensitivity test that distinguishes between indicationsassociated with different proteins (e.g., to provide a more detailedanalysis, to identify other sources of the protein that may causeimmunological reactions, etc.).

In some implementations, the food sensitivity testing system may includeutilizing successively specific food sensitivity tests to reduce thenumber of tests to perform, to facilitate usability by the user, toreduce costs, to provide specificity requested from a user, etc. Forexample, one or more first food sensitivity test may be used to identifywhether a person has food sensitivities to a first set of foods. If theresults are negative (e.g., no food sensitivity detected), then ratherthan having to purchase and perform a test for each of the foodsindividually a single test may provide results. If a result is positive(e.g., a food sensitivity detected), then additional testing may beperformed using second food sensitivity tests. For example, the secondfood sensitivity tests may identify a smaller second set of foodsensitivities than the first set of foods. The second set may beassociated with one or more foods. Additional tests, such as third foodsensitivity tests may be performed based on the results of the secondfood sensitivity tests.

In various implementations, a food sensitivity test may allowidentification of a set of food sensitivities in people. FIG. 2illustrates an implementation of an example of a process for identifyingfood sensitivities. A fecal sample may be obtained (operation 210). Thefecal sample may be tested using the food sensitivity test (operation220). During testing of fecal samples with the food sensitivity test,the food sensitivity test may be contacted with a fecal sample. Forexample, supernatant liquid from a fecal sample may be deposited on thefood sensitivity test. In some implementations, the food sensitivitytest may be dipped into the fecal sample. The fecal sample may beprocessed to bind a flag (e.g., color, fluorescence, magnetic flag,and/or other detectable indicators) to a predetermined antibody, ifpresent in the fecal sample. The flag may be activated (e.g., the colormay change, the flag may fluoresce, etc.) when the flag is coupled to anantibody binding agent, in some implementations. In someimplementations, fluids in at least a portion of the fecal sample mayflow through (e.g., through a chamber, through channel(s), etc.) a flagregion such that predetermined antibodies, if present in the fecalsample, may contact and couple with the flag. Thus, when the foodsensitivity test is contacted with the fecal sample, if antibodies arepresent in the fecal sample, the antibodies will couple with theantibody binding agents on the substrate of the test and the flag may beactivated.

One or more food sensitivities may be identified based at leastpartially on the food sensitivity test (operation 230). For example, thefecal sample obtained from a person may include food specific IgA, inlevels detectable by the food sensitivity test. Activation of theflag(s) in the testing region may provide indicia to facilitateidentification of the predetermined antibody in the fecal sample, andthus food sensitivity related the predetermined antibody.

In some implementations, the food sensitivity test may include a teststrip. The test strip may include antibody binding agent that whencoupled to a predetermined antibody produces an indicia (e.g., colorchange, fluorescence, etc.).

In some implementations, one or more food sensitivity tests may beperformed on the same fecal sample (e.g., the same testing portionand/or another testing portion from the same fecal sample). For example,a food sensitivity test may be associated with a first set of foods(e.g., common allergens, gluten panel, grain panel, additives panel,and/or any other appropriate set that can be performed together). Thefirst food sensitivity test may produce a first result (e.g., foodsensitivity to one or more of the first set of food sensitivities).Subsequent food sensitivity test(s) may be performed based on the firstresults from the first food sensitivity test. For example, if a firstfood sensitivity test does not distinguish between the food sensitivityin the first set (e.g., a positive or negative reactivity is producedfor the overall set), and the first result is positive reactivity thenone or more subsequent food sensitivity tests may be performed tospecify the identify of the food sensitivity (e.g., the subsequent testmay include a portion of the food sensitivities in the first set of foodsensitivities associated with the first test). In some implementations,if a first food sensitivity test is negative, then subsequent foodsensitivity test(s) may be performed with one or more second sets offood sensitivities (e.g., including at least one different foodsensitivity from the first set of food sensitivities). In someimplementations, by testing for multiple food sensitivities with onefood sensitivity test, costs may be reduced and results may be obtainedmore quickly (e.g., when compared with running a screening of aplurality of food sensitivities).

In some implementations, a user may purchase a kit of food sensitivitytest(s) and select one or more to perform on a fecal sample. In someimplementations, a user may purchase a kit with a fecal collection toolintegrated with one or more food sensitivity test(s) and one or moreseparate food sensitivity test(s). The user may determine which, if anyseparate food sensitivity test(s) to perform based on the results fromthe food sensitivity test(s) integrated with the fecal collection tool.For example, a user use separate food sensitivity test(s) associatedwith different sets of food sensitivities and/or subsets of the foodsensitivities tested for using the integrated food sensitivity test(s).In some implementations, the separate food sensitivity test(s) may beutilized for confirmatory testing.

In some implementations, the fecal sample may be processed and/orunprocessed prior to allowing the food sensitivity test to identify foodsensitivities. For example, the fecal sample may be obtained and anundiluted and/or unconcentrated fecal sample may be utilized with thefood sensitivity test. In some implementations, a food sensitivity testmay be dipped into an undiluted and unconcentrated fecal sample.

In some implementations, the fecal sample may be concentrated prior toallowing the food sensitivity test to identify food sensitivities. Afecal sample may be obtained and concentrated. For example, the fecalsample may be centrifuged (e.g., at approximately 13,500rpm-approximately 20,000 rpm or any appropriate velocity). Thesupernatant liquid from the centrifuged fecal sample may be collected,in some implementations. The food sensitivity test may be performed onthe supernatant liquid. For example, the food sensitivity test may bedipped into the supernatant liquid to identify food sensitivities.

In some implementations, the fecal sample may be overly watery (e.g.,due to diarrhea). The fecal sample may be concentrated to facilitateidentification of food sensitivities. For example, the fecal sample maybe freeze dried. The solid freeze dried fecal sample obtained may thenbe reconstituted with a hydrating agent (e.g., water) to an appropriatemoisture content (e.g., to allow appropriate testing using the foodsensitivity test). For example, the percentage of dry to wet may beapproximately 25 percent to approximately 75 percent and/or any otherappropriate ratios. In some implementations, the freeze dried fecalsample may be reconstituted to a similar moisture content ofnon-diarrhea stool (e.g., less than the moisture content of the originalfecal sample).

In some implementations, the fecal sample may be overly dry (e.g., dueto constipation and/or moisture loss due to age of fecal sample). Thefecal sample may be hydrated to allow moisture to transport theantibodies, if present in the fecal sample, into the food sensitivitytest. For example, water or another hydrating agent may be added to thefecal sample. The hydrating agent may be added to the fecal sample toobtain a moisture content in a predetermined range (e.g., approximately25 percent to approximately 75 percent, a moisture content associatedwith nonconstipated stool, a moisture content that allows transportationof antibodies present in the fecal sample through the absorbent regionof the food sensitivity test and/or any other appropriate moisturecontent). In some implementations, the fecal collection tool may be usedto mix the fecal sample and the water. The hydrated fecal sample maythen be utilized with the food sensitivity test. For example, the foodsensitivity test may be dipped into the hydrated fecal sample.

Although food sensitivities have been used to describe an immunologicsensitivity to a food, food sensitivity may also refer to an immunologicsensitivity to a particular food substance. For example, foodsensitivity may refer to an immunologic sensitivity to a food dye. Foodsensitivity may refer to an immunologic sensitivity to a food additive.In some implementations, food sensitivity may refer to an immunologicsensitivity to a vitamin, supplement, nutraceutical, pharmaceutical,and/or other products consumed by a person.

The food sensitivity tests may be for use in a clinical (e.g., in officeand/or point of care testing), laboratory, and/or home environment.

In various implementations, diagnosing of food sensitivities using thefood sensitivity test has been described. The presence of specific IgAmay be used to identify food sensitivities and/or diseases and/or rangesof IgA that indicate food sensitivity, are described in U.S. Pat. No.6,667,160 to Fine and U.S. Pat. No. 7,604,957 to Fine, which areincorporated by reference to the extent that the patents are notcontradictory to the disclosure provided herein.

In various implementations, an agent has been described. An agent mayinclude antibodies, antigens, cells, enzymes, markers, and/or portionsthereof

In various implementations, selective coupling has been described.Selective coupling may include allowing coupling between a first agentand one or more second agent and restricting coupling between the firstagent and one or more third agents. The second agents may include asingle type of or multiple types of the agent. The third agent mayinclude a single type of agent and/or multiple types of agents.

Although users have been described as a human, a user may be a person ora group of people.

It is to be understood the implementations are not limited to particularsystems or processes described which may, of course, vary. It is also tobe understood that the terminology used herein is for the purpose ofdescribing particular implementations only, and is not intended to belimiting. As used in this specification, the singular forms “a”, “an”and “the” include plural referents unless the content clearly indicatesotherwise. Thus, for example, reference to “a food” includes acombination of two or more foods and reference to “a test” includesdifferent types and/or combinations of tests.

Although the present disclosure has been described in detail, it shouldbe understood that various changes, substitutions and alterations may bemade herein without departing from the spirit and scope of thedisclosure as defined by the appended claims. Moreover, the scope of thepresent application is not intended to be limited to the particularembodiments of the process, machine, manufacture, composition of matter,means, methods and steps described in the specification. As one ofordinary skill in the art will readily appreciate from the disclosure,processes, machines, manufacture, compositions of matter, means,methods, or steps, presently existing or later to be developed thatperform substantially the same function or achieve substantially thesame result as the corresponding embodiments described herein may beutilized according to the present disclosure. Accordingly, the appendedclaims are intended to include within their scope such processes,machines, manufacture, compositions of matter, means, methods, or steps.

1. A diagnostic test kit to identify food sensitivity in humans, whereinthe kit comprises: a diagnostic test to identify the presence of a firstset of food sensitivities in a human, wherein the diagnostic testcomprises: a substrate; and a test region, wherein the test regioncomprises one or more antibody binding agents coupled to the substrate,wherein at least one of the antibody binding agents is adapted to coupleto one or more first antibodies associated with one or more foodsensitivities in the first set of food sensitivities when one or more ofthe first antibodies is present in a fecal sample obtained from thehuman; wherein the diagnostic test is configured to contact the fecalsample of the human to allow identification of the presence of the firstset of food sensitivities; and wherein one or more of the firstantibodies, if present in the fecal sample, is transferred to the testregion of the diagnostic test by the contact.
 2. The kit of claim 1wherein the diagnostic test comprises a stick test, and wherein thestick test comprises: a first end, wherein the first end comprises ahandle to allow a user to hold the stick test without contacting thefecal sample; and a second opposing end, wherein the second opposing endcontacts the fecal test to allow transfer of one or more of the firstantibodies, if present in the fecal sample, to the test region of thediagnostic test.
 3. The kit of claim 1 wherein the diagnostic testfurther comprises an absorbent region adapted to transfer a testingportion of a fecal sample from the fecal sample to the test region ofthe diagnostic test, wherein the absorbent region contacts the fecalsample and absorbs fluid from the fecal sample to transfer to the testregion, and wherein the fluid from the fecal sample comprises at least aportion of the antibodies present in the fecal sample.
 4. The kit ofclaim 1 wherein the diagnostic test further comprises one or more flagsadapted to indicate coupling of one or more first antibodies in a fecalsample with one or more of the antibody binding agents of the diagnostictest, and wherein one or more of the flags provides a visual indicationthat at least one of the first set of food sensitivities is present inthe human associated with the fecal sample.
 5. The kit of claim 1wherein the diagnostic test is adapted to allow fluid from the fecalsample to flow between two or more regions of the diagnostic test. 6.The kit of claim 1 wherein at least one of the antibody binding agentscomprises an IgA conjugate associated with an IgA antibody associatedwith one or more food sensitivities in the set of food sensitivities,wherein the IgA conjugate binds to the IgA antibody when the IgAantibody is proximate the IgA conjugate.
 7. The kit of claim 1 whereinthe testing region comprises one or more flags coupled to one or more ofthe antibody binding agents such that each flag is altered when anantibody from a fecal sample couples with an antibody binding agent, andwherein altering one or more of the flags produces a visuallyidentifiable change.
 8. The kit of claim 1 wherein the testing regioncomprises a plurality of different antibody binding agents associatedwith a plurality of different food sensitivities.
 9. The kit of claim 1wherein the diagnostic test is integrated with a specimen container,wherein the specimen container is adapted to allow a testing portion ofthe fecal sample to be disposed in the specimen container to allowidentification of the first set of food sensitivities, and wherein thediagnostic test is positioned in the specimen container to allow contactwith the testing portion of the fecal sample.
 10. A diagnostic test kitto identify food sensitivity in humans, wherein the kit comprises: afecal sample collection tool; and one or more diagnostic tests toidentify the presence of a first set of food sensitivities in a human,wherein each of the diagnostic tests are integrated with the fecalsample collection tool, and wherein each of the diagnostic testscomprise: a substrate; and a test region, wherein the test regioncomprises one or more antibody binding agents coupled to the substrate,and wherein at least one of the antibody binding agents is adapted tocouple to one or more first antibodies associated with the first set offood sensitivities when one or more of the first antibodies is presentin the fecal sample obtained from the human; wherein the fecal samplecollection tool is adapted to allow at least one of the diagnostic teststo contact the fecal sample to allow identification of the presence ofthe first set of food sensitivities; and wherein one or more of thefirst antibodies, if present in the fecal sample, is transferred to thetest region of at least one of the diagnostic tests by the contact. 11.The kit of claim 10 wherein one or more of the diagnostic test ispositioned in the fecal sample collection tool such that the diagnostictest contacts the fecal sample during collection of the fecal sample.12. The kit of claim 10 wherein one or more of the diagnostic tests arepositioned on the fecal sample collection tool such that a testingportion of the fecal sample is moved by a user to contact one or more ofthe diagnostic tests and allow identification of the first set of foodsensitivities.
 13. The kit of claim 10 wherein the fecal samplecollection tool includes an opening to allow at least a portion of fluidfrom a fecal sample to drain from the fecal sample collection tool. 14.The kit of claim 10 wherein the fecal sample collection tool is adaptedto allow at least one of a hydrating agent or a solution including flagsto be applied to the fecal sample in the fecal sample collection tool.15. The kit of claim 10 wherein at least one of the diagnostic testscomprises one or more flags adapted to indicate coupling of one or morefirst antibodies in the fecal sample with one or more of the antibodybinding agents, and wherein one or more of the flags provides a visualindication that at least one of the first set of food sensitivities ispresent in the human associated with the fecal sample.
 16. The kit ofclaim 10 wherein the fecal sample collection tool comprises a removablestop, and wherein the stop is adapted to close an opening in the fecalsample collection tool, and wherein when the stop is removed at leastone of fluid and/or the fecal sample may be drained from the fecalsample collection tool via the opening.
 17. The kit of claim 10 whereinthe diagnostic test comprises a plurality of antibody binding agentsassociated with a set of foods.
 18. The kit of claim 10 wherein at leastone of the antibody binding agents comprises an IgA conjugate associatedwith an IgA antibody associated with one or more food sensitivities inthe set of food sensitivities, wherein the IgA conjugate binds to theIgA antibody when the IgA antibody is proximate the IgA conjugate. 19.The kit of claim 10 wherein the testing region comprises one or moreflags coupled to one or more of the antibody binding agents such thatwhen an antibody couples with an antibody binding agent the flag isaltered.
 20. The kit of claim 10 wherein each of the diagnostic tests isadapted to provide a visually identifiable change to identify thepresence of the first set of food sensitivities in the fecal sample.